Effects of Two Herbal Dietary Supplements on Lipid Metabolism in Moderate Hypercholesterolemia and Hypertriglyceridemia

NCT02989753 | Completed Phase 1 DMC

• 1 other identifier: 2016-A01178-43
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a pilot study in order to estimate the effect of VAL070-A and VAL070-B products and their variability on LDL cholesterol and lipid metabolism since these data are still unknown for these products and in this specific population. Collected data will provide more reliable information which may be used to plan a subsequent larger main study.

Conditions

Hypercholesterolemia; Hypertriglyceridemia

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

• Comparison between VAL070-B and placebo on changes between V1 and V2 visits of the fasting blood LDL cholesterol

  Defined as the difference V2 (12 weeks) - V1 (baseline) in g/L

  12 weeks

Secondary Outcomes (22)

• Comparison between VAL070-A and placebo on changes between V1 and V2 visits of the fasting blood LDL cholesterol

  12 weeks

• Changes in fasting blood concentrations of triglycerides

  12 weeks

• Changes in fasting blood concentrations of total cholesterol

  12 weeks

• Changes in fasting blood concentrations of HDL cholesterol

  12 weeks

• Changes in fasting blood concentrations of non-HDL cholesterol

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

The comparative product is a placebo with the same characteristics of appearance and packaging as studied products and in which all ingredients are replaced by maltodextrin.

Dietary Supplement: Placebo

VAL070-A

EXPERIMENTAL

Studied active product n°1, named VAL070-A, is a dietary supplement in shape of capsule. VAL070-A product contains 4 active plant extracts.

Dietary Supplement: VAL070-A

VAL070-B

EXPERIMENTAL

Studied active product n°2, named VAL070-B, is a dietary supplement in shape of capsule. VAL070-B product contains 5 active plant extracts.

Dietary Supplement: VAL070-B

Interventions

VAL070-A DIETARY_SUPPLEMENT

After randomization (V1 visit), 8 capsules per day of VAL070-A during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.

VAL070-A

VAL070-B DIETARY_SUPPLEMENT

After randomization (V1 visit), 8 capsules per day of VAL070-B during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.

VAL070-B

Placebo DIETARY_SUPPLEMENT

After randomization (V1 visit), 8 capsules per day of placebo during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years (limits included),
• BMI between 18.5 and 40 kg/m2 (limits included),
• For women: Non menopausal with the same reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study (condom with spermicide gel and estrogen/progestin combination contraception accepted) or menopausal without or with hormone replacement therapy (estrogenic replacement therapy begun from less than 3 months excluded),
• Weight stable within ± 5 % in the last three months,
• Non smoking or with tobacco consumption \< 20 cigarettes / day,
• Good general and mental health with in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination,
• Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form,
• Affiliated with a social security scheme,
• Agree to be registered on the volunteers in biomedical research file.
• After V1 biological analysis the subjects will be eligible to the study on the following criteria:
• Fasting blood LDLc level (using Friedewald estimation method) between 1.3 and 2.2 g/L (limits included with ± 2 % tolerated around),
• Fasting blood triglycerides level \> 1.5 g/L,
• Blood TSH level between 0.27 and 4.2 μIU/mL (limits included).

You may not qualify if:

• Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder,
• Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator (e.g. celiac disease),
• With a history of ischemic cardiovascular event,
• Having undergone recent surgical procedure (less than 6 months),
• Suffering from an uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg),
• With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredient,
• Pregnant or lactating women or intending to become pregnant within 3 months ahead,
• For women: pregnancy or breastfeeding finished since less than 6 months,
• Under cholesterol and/or lipid-lowering treatment (e.g. statins, fibrates, ezetimibe, bile acid sequestrants, niacin, etc.) or stopped less than 3 months before the V1 visit,
• Requiring a cholesterol lowering by immediate pharmacologic intervention according to the current recommendations (AFSSAPS, 2005),
• Under medication which could affect blood lipid parameters (e.g. long-term corticosteroid systemic drug, systemic antibodies, androgens or enzyme inducer, etc.) or stopped less than 3 months before the randomization (antihypertensive stable long-term treatment tolerated),
• Regular intake of dietary supplements or "functional foods" which are known to have an impact on lipid metabolism (e.g. rich in plant stanol or sterol like PRO-ACTIV or DANACOL products, red yeast rice, policosanol, capsules containing omega-3 fatty acids from fish oils, containing beta glucanes, konjac extract or cinnamon, etc.) or stopped less than 3 months before the V1 visit,
• Under treatment or dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the V1 visit,
• With significant change in food habits or in physical activity in the 3 months before the V1 visit or not agreeing to keep them unchanged throughout the study,
• With a current or planned in the next 3 months specific diet (hyper or hypocaloric, vegan, vegetarian...) or stopped less than 3 months before the study,

Sponsors & Collaborators

• Valbiotis: lead
• Biofortis Mérieux NutriSciences: collaborator

Study Sites (1)

Biofortis Mérieux NutriSciences Clinical Investigation Center

Saint-Herblain, 44800, France

Location

MeSH Terms

Conditions

Hypercholesterolemia; Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David GENDRE, Dr

  Biofortis Mérieux NutriSciences

  PRINCIPAL INVESTIGATOR

• Jean-Marie BARD, Dr-PhD

  UFR des Sciences Pharmaceutiques et Biologiques, Nantes, France

  STUDY CHAIR

• Sébastien PELTIER, PhD

  Valbiotis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 12, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 5, 2018

Record last verified: 2017-05

Locations

FR (1)